A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Histoplasmosis; Blastomycosis
Intervention: Itraconazole (Drug); Amphotericin B (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Janssen, LP
Summary
To assess the safety of intravenous itraconazole compared to amphotericin B in HIV positive
or negative persons with blastomycosis or histoplasmosis.
Clinical Details
Official title: A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis
Study design: Treatment
Detailed description:
Patients are randomized to receive IV itraconazole for 2 days, then either itraconazole daily
for 5 days or amphotericin B daily for 7 days. IV treatment is followed by consolidation with
oral itraconazole for up to 1 year.
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
Patients must have:
- HIV positive or negative status.
- Blastomycosis or histoplasmosis.
- Life expectancy of at least 1 week.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Liver disease.
- Self-limiting fungal disease.
- Very severe fungal disease such as meningeal involvement.
- Acute respiratory disease.
Concurrent Medication:
Excluded at any time:
- Terfenadine.
- Astemizole.
- Oral midazolam.
- Triazolam.
- Cisapride.
- Phenytoin.
- Phenobarbital.
- Rifampin.
- Rifabutin.
Excluded during oral consolidation:
- H2 blockers.
- Chronic antacids.
- Omeprazole.
- Lansoprazole.
Patients with the following prior condition are excluded:
Hypersensitivity to azole antifungals.
Prior Medication:
Excluded at any time:
More than 3 days of amphotericin B, fluconazole, or ketoconazole.
Excluded within 2 weeks prior to study entry:
- Phenytoin.
- Phenobarbital.
- Rifampin.
- Rifabutin.
Locations and Contacts
UAB Station / Infectious Division, Birmingham, Alabama 35294, United States
Univ of Arkansas for Med Sciences, Little Rock, Arkansas 72205, United States
Division of Infectious Diseases, Atlanta, Georgia 30303, United States
Division of Inf Diseases/ Indiana Univ Hosp, Indianapolis, Indiana 46202, United States
Community Hosp, Indianapolis, Indiana 46218, United States
LSU Med Ctr / Div of Pulmonary & Critical Care Med, Shreveport, Louisiana 71130, United States
Ann Arbor Veterans Administration Med Ctr, Ann Arbor, Michigan 48105, United States
Infectious Diseases Association / Research Med Ctr, Kansas City, Missouri 64132, United States
Univ of Missouri / Division of Infectious Diseases, Kansas City, Missouri 641082792, United States
Additional Information
Last updated: June 23, 2005
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